Trials / Completed
CompletedNCT05932433
Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Universidad Rey Juan Carlos · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to evaluate the effect of therapeutic exercise on the gut microbiome in chronic widespread pain patients. Our investigation purpose is to improve the quality of life of participants, reduce their disability and optimize their functionality. The intervention will last 6 weeks, with 2 face-to-face therapeutic exercise sessions guided by a professional and a 6-week post-intervention follow-up. The participation will require: 1. Attend the 12 therapeutic exercise sessions 2. Attend the 3 evaluations: at the beginning (A0), post intervention (A1) and +6 weeks after finishing the exercise program (A3). The items to be evaluated will be the following: 1. The Ronald Morris Disability Questionnaire (RMDQ) 2. Anxiety (State-Trait Anxiety Inventory (STAI)) 3. Depression: Beck Depression Inventory (BDI) 4. Quality of Life: SF-12 5. Pain: numerical scale (0-100) and The Brief Pain Inventory (BPI) 6. Sensory tests: heat pain threshold (HPT), pressure pain threshold (PPT) and pain modulation (CPM) 7. Perform a pre blood test on interleukins IL-18 and IL-1β This study involves the processing of personal data, so the researchers will guarantee confidentiality in their treatment at all times, complying with the personal data protection regulations, in particular, European Regulation 679/2016. , of April 27, general data protection, as well as Organic Law 3/2018, of December 5, Protection of Personal Data and Guarantee of Digital Rights. In order to maintain your privacy and anonymity during the research, only one person on the research team will know how names were assigned to a participation number.
Conditions
- Arthritis
- Fibromyalgia
- Arthritis Rheumatoid
- Artrosis of the Knee
- Chronic Pain
- Central Sensitisation
- Gut Microbiota
- Exercise Therapy
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Exercise | Each session (45 minutes aprox) is made by: mobility, endurance and final exercise to rest. The sesion is going to perform twice a week during 6 weeks. |
Timeline
- Start date
- 2023-05-01
- Primary completion
- 2023-06-01
- Completion
- 2023-06-10
- First posted
- 2023-07-06
- Last updated
- 2023-07-06
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05932433. Inclusion in this directory is not an endorsement.